Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000083695
Ethics application status
Approved
Date submitted
7/01/2014
Date registered
22/01/2014
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
REducing AntiPsychotic use in residential care: Huntington Disease. A pilot Randomised Controlled Trial
Scientific title
A randomised controlled trial comparing a multi-faceted intervention based on a behavioural management clinical pathway for health professionals (MFI), against standard staff outreach education (SSE), in reducing anti-psychotic dosages for people with Huntington Disease (HD) in residential care facilities (RCF)
Secondary ID [1] 283863 0
Nil
Universal Trial Number (UTN)
Trial acronym
REAP-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington Disease
 290844 0
Antipsychotic use 290845 0
Condition category
Condition code
Neurological 291208 291208 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 291323 291323 0 0
Other human genetics and inherited disorders
Public Health 291324 291324 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multi-faceted intervention (MFI) is based on a clinical pathway for management of behavioural symptoms. It comprises a once-off 45 minute presentation and a followup phone call at 1 month.
Intervention code [1] 288540 0
Other interventions
Comparator / control treatment
Standard staff outreach education- it comprises a once-off 45 minute presentation and a followup phone call at 1 month.This represents current best practice.
Control group
Active

Outcomes
Primary outcome [1] 291197 0
Proportion of people with HD who has had a reduction in antipsychotic dosage at 4 months, in RCF receiving MFI vs. SSE. Dosage will be assessed as per medication chart, including all regular and prn doses for 1 week prior to each time-point. Any change in antipsychotic type will be managed by calculating dose equivalence.
Timepoint [1] 291197 0
At 4 months post intervention
Secondary outcome [1] 306220 0
Changes in the severity of behavioural symptoms, as measured by the Neuropsychiatric Inventory-Q (NPI-Q).
Timepoint [1] 306220 0
At 4 months post intervention
Secondary outcome [2] 306221 0
Proportion of people with HD who has had a reduction in antipsychotic dosage at 4 months for each strategy, compared to 4 months prior to enrolment. This secondary outcome takes a 'before and after' analysis approach, often used in health services research. It incorporates all three time points- 4 months pre enrolment, at enrolment, and 4-months post enrolment.
Timepoint [2] 306221 0
At 4 months post intervention

Eligibility
Key inclusion criteria
1.Male or Female 18 years or older
2.Clinical HD, and a confirmatory family history OR >= 36 CAG repeats upon genetic testing
3.Living in RCF in NSW- including group homes with 24-hour supervision, hostels and nursing homes
4.Currently receiving a stable dose of regular antipsychotic medications for management of behavioural symptoms, for at least 4 months prior to enrolment (see exclusion criteria).
5.Able to provide informed consent, or have a suitable senior person responsible who is able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Change of antipsychotic dose within 4 months prior to enrolment
2.Psychotic symptoms (new hallucinations or delusions) within 1 year of enrolment
3.People taking anti-psychotic medications solely for control of chorea
4.Other unstable medical or psychiatric illness, making it unsafe to reduce anti-psychotic dose

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment by experienced HD nurse. Enrolled after consent by person/family with HD, consent by Residential Care Facility representative, and confirmation of inclusion/exclusion criteria.
Off-site biostatistician randomisation. Biostatistician will then inform the study staff re allocation of treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using SAS, with randomisation block size blinded to the study staff.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Since there are only a small number of RCF with more than one HD resident, and cluster size is not uniform across RCF, it will be difficult to take into account clustering in sample size calculation. For sample size calculation, we will therefore only ‘count’ one resident from each of RCF. Difference in primary outcome (proportion of people with HD who has had a reduction in antipsychotic use) between the two arms of the RCT, will be expressed in terms of absolute risk reduction, and relative risk reduction. Statistical significance between the two proportions will be tested with a Chi-squared test (p<0.05).
The likely effect size for MFI or SSE on the primary outcome is unknown. This trial is therefore designed as a pilot study, with 19 participants in each arm. This represents approximately 30% of nursing home in NSW looking after people with HD. Anecdotally, we have not seen any antipsychotic reduction in RCF, following our previous education sessions. So assuming that antipsychotic will be reduced in 5% of people in the SSE arm, our sample size will be able to detect a difference of 50% vs 5% in the primary outcome for MFI vs. SSE, with a power of 82% (alpha=0.05). Changes in NPI-Q will be analysed using the paired t-test. All analysis will be carried out on an Intention-To-Treat basis.
If there are additional residents available at a RCF, they can also be included in the study and the final statistical analysis will take into account the clustering.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2014
Actual
25/02/2014
Date of last participant enrolment
Anticipated
30/06/2014
Actual
10/09/2014
Date of last data collection
Anticipated
Actual
14/01/2015
Sample size
Target
38
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1935 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 7680 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288510 0
Government body
Name [1] 288510 0
NHMRC TRIP fellowship
Country [1] 288510 0
Australia
Primary sponsor type
Hospital
Name
Huntington Disease Service, Westmead Hospital
Address
Westmead Hospital, Hawkesbury Rd, Westmead. NSW 2145 Australia.
Country
Australia
Secondary sponsor category [1] 287216 0
None
Name [1] 287216 0
Address [1] 287216 0
Country [1] 287216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290372 0
Western Sydney Local Health District HREC Committee
Ethics committee address [1] 290372 0
Ethics committee country [1] 290372 0
Australia
Date submitted for ethics approval [1] 290372 0
26/06/2012
Approval date [1] 290372 0
01/03/2013
Ethics approval number [1] 290372 0
HREC2012/6/4.8(3535) AU RED HREC/12/WMEAD/197

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45366 0
Dr Clement Loy
Address 45366 0
Director, Huntington Disease Service
Westmead Hospital
Hawkesbury Rd,
Westmead
NSW 2145
Country 45366 0
Australia
Phone 45366 0
+61-2-98456793
Fax 45366 0
Email 45366 0
[email protected]
Contact person for public queries
Name 45367 0
Clement Loy
Address 45367 0
Director, Huntington Disease Service
Westmead Hospital
Hawkesbury Rd,
Westmead
NSW 2145
Country 45367 0
Australia
Phone 45367 0
+61-2-98456793
Fax 45367 0
Email 45367 0
[email protected]
Contact person for scientific queries
Name 45368 0
Clement Loy
Address 45368 0
Director, Huntington Disease Service
Westmead Hospital
Hawkesbury Rd,
Westmead
NSW 2145
Country 45368 0
Australia
Phone 45368 0
+61-2-98456793
Fax 45368 0
Email 45368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.